What constitutes a document revision

Hi,

My company currently operates a paper based document control system.  Many of our production records which are filled in on a daily basis are undergoing dozens of revisions.  The main problem is that the document lists products pre printed on the record but these products are constantly changing through-out the year which results in a change request being sent.

My question is... should a controlled document be expected to even contain the product list?  Or would you expect the document control department to just have a blank copy of this document with no product names on?  If this is the case i think i need to understand a little better of what information within a document is needed to be controlled and what isn't as this is causing certain documents to revised on a weekly basis.

Kind regards,

Matt

Hi Matt, welcome to the IFSQN.

Hypothetically, if you just made the document template subject to revision control and the data on it (product list) not subject to revision...could this cause a problem to product safety or quality?  What could go wrong?

Once we know this then we can be of more assistance.

My preference is to have the template controlled and have the products filled in by hand. This eliminates the need to revise when the products change.

The way I do it, minor revisions to a document, such as fixing typos or minor clarifications receive a minor revision update. (i.e., Version #1.0 becomes Version # 1.1)

Major revisions to content of a document receive a major revision update. (i.e. Version # 1.3 becomes Version # 2.0)

As Simon says, your particular situation may dictate your actions.

Marshall

Dear Msollis,

A controlled document is a reference document which, through the course of its lifecycle may be reviewed, modified and distributed several times. Examples of a controlled document include: technical drawings, specifications, procedures, data-sheets, contracts, application forms and plans.

 

http://www.qa-softwa...ed-document.htm

The specific  document related data typically placed in headers/footers  may relate to the relevant standard but invariably includes some form of revision “identification” for obvious reasons.

Some aspects are subjective, my document control procedure states that minor revisions, eg typos, will not necessitate an updated revision number. But the changes you refer to are anyway hardly minor.

Clearly a manual procedure solves the problem but looks a headache if your list length is typical of routine running. Assuming that the range of possible items is known, it seems to me that it should be acceptable for the list to  include non-current items (ie giving blank data entries), but not the reverse situation. But whether this would then create unacceptable operational/tracking problems ….? (IMEX storage records for products / packaging often contain “numerous”  antique zeros due to such procedures, the entries hurriedly deleted prior to external inventory audits :smile: ).

Rgds / Charles.C

PS – I have also seen manoeuvres as per Simon’s post but whether such methods are generically supportable. :unsure:

Maybe you can have the controlled document discuss how this list is used, and have there be an exemplar list as the template.  The controlled document can give the procedure for maintaining the current salad list to be used for the template, where and how that is stored, how the list is permitted to be changed, but not the current list itself.

That way, the list is not a controlled document, but the procedure of using/changing/storing the list is.

Martha

A blank form will do.  What you are controlling is just the format and data that needs to fill-up.

A blank form will do.  What you are controlling is just the format and data that needs to fill-up.

Dear virgo,

Sounds like the hypothetical post #2.

It's an interesting proposal. Any related validatory links known ?

Rgds / Charles.C